The Independent Medicines and Medical Devices Safety (IMMDS) Review: First do no harm (Cumberlege Review), published in 2020, looked at the management of cases where patients and their families had raised serious concerns relating to the use of 2 medicines and 1 implantable medical device.

Government endorsed Recommendation 7 of the review:

“A central patient-identifiable database should be created by collecting key details of the implantation of all devices at the time of the operation. This can be linked to specifically created registers to research and audit the outcomes both in terms of the device safety and patient reported outcomes measures.”

The Medical Devices Outcomes Registry (MDOR) data collection (formally the Surgical Devices and Implants Core Data Set) was established in 2024 to fulfil this recommendation, for the NHS (England, Scotland and Wales), healthcare organisations in Northern Ireland and independent sector organisations. It improves patient safety and outcomes by enabling surveillance of implantable medical devices through linkage of component data modules, including associated patient outcomes, to support patient focused activities such as the review or recall of implantable medical devices.

By collecting data to improve patient safety, vigilance and outlier analysis and reduce variation in clinical practice, the MDOR also contributes to meeting the government’s response to the Paterson Inquiry in 2020 into the circumstances regarding clinical malpractice in both the NHS and independent healthcare sector. Recommendation 1 stated:

“There should be a single repository of the whole practice of consultants across England, setting out their practising privileges and other critical consultant performance data, for example, how many times a consultant has performed a particular procedure and how recently. This should be accessible and understandable to the public. It should be mandated for use by managers and healthcare professionals in both the NHS and independent sector.”

About the MDOR

The Secretary of State for Health and Social Care directs NHS England to operate the MDOR.

To fulfil the recommendations of the Cumberlege Review and Paterson Inquiry, the MDOR captures data on the healthcare provider, patient, operation, clinician and implantable medical device(s).

All healthcare organisations, including independent sector organisations, that provide NHS-funded care and undertake surgical or interventional procedures involving a Class IIb or III implantable medical device must comply with the requirement to submit data to NHS England. Independent sector organisations that provide privately-funded care for the same procedures may submit data to NHS England on a voluntary basis.

MDOR data collection

Data submissions to the MDOR through the Outcomes and Registries Clinical Application started in April 2024. Access to the system is via an approved account and requires log in.

Data is collected daily and can be entered 24 hours a day, 365 days a year. The collection is ongoing with no end date.

Supporting documentation

More information on the MDOR and the wider work on the Outcomes and Registries Programme can be found in:

• Outcomes and Registries Directions 2024 outlining the legal requirement from the Secretary of State for NHS England to collect these data
• MDOR requirements specification detailing what providers in scope must do to comply with the mandate to submit data
• MDOR data specification defining what data fields are to be collected to fulfil the legal requirement
• MDOR data provision notice detailing the legal instruction to providers in scope to submit data
• MDOR transparency notice informing data subjects (patients and the public) how and why NHS England collects, uses, stores and shares their personal data

Enquiries

For MDOR general enquiries and support, please contact england.mdor.outcomesandregistries@nhs.net.

For technical support from the Outcome Registries Clinical Application liaison team, please contact england.support.outcomeregistries@nhs.net.